Effect of Protein Source During Ketogenic Weight Loss Intervention

January 13, 2026 updated by: Concordia University, Montreal

Effect of Protein Source During Ketogenic Weight Loss Intervention on Lipid Metabolism and Inflammation

This randomized, controlled, single-blinded study will investigate how the protein source in a high-protein ketogenic diet affects metabolic weight loss outcomes after a 12-week dietary intervention

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized, controlled, single-blinded study will compare how a ketogenic weight loss diet, supplemented with either animal- or plant-based protein affects: (i) metabolic markers (adipokine and cytokine) in adipose tissue and blood, (ii) adipose tissue immune cell profiles, and (iii) adipocyte characteristics and their interaction with other cells (e.g. immune cells and muscle cells). To better determine how tissue characteristics affect the whole body level, the relationships between adipose tissue characteristics and blood lipid and inflammatory markers will also be examined. Participants undergo anthropometric measurements, questionnaires, body composition assessment, energy assessment, blood draws, and adipose tissue biopsies from the abdominal and femoral adipose tissue depots

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4B 1R6
        • School of Health, Concordia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults between 18-60 years old
  • BMI: >29.99kg/m2

Exclusion Criteria:

  • Any chronic metabolic conditions (e.g. CVD)
  • Renal impairment (creatinine clearance <60 mL/min)
  • Uncontrolled hypothyroidism
  • Pregnant, breastfeeding, or postmenopausal females
  • Past (<6 year) or present use of nicotine products
  • Use of cannabis products
  • Use of any other medications that may affect study outcomes (e.g. anti-depressants)
  • Participants who have had a number of CT scans in the course of the year
  • Participants following a vegan diet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plant-based pea/lupine protein supplement
Dietary supplement: Protein supplement - Plant protein
Pea/lupine protein powder mix
Experimental: Animal-based whey protein supplement
Dietary supplement: Protein supplement - Animal protein
Whey protein powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight
Time Frame: Baseline and at 12 weeks
Overall weight loss, kg
Baseline and at 12 weeks
Change in BMI
Time Frame: Baseline and at 12 weeks
Height and weight will be combined to report BMI (kg/m^2)
Baseline and at 12 weeks
Change in fat mass
Time Frame: Baseline and at 12 weeks
Body composition is measured by dual energy x-ray absorptiometry.
Baseline and at 12 weeks
Change in overall body fat percentage
Time Frame: Baseline and at 12 weeks
Body composition is measured by dual energy x-ray absorptiometry.
Baseline and at 12 weeks
Regional subcutaneous adipose tissue immune cells ( number of cells per gram tissue, percentage of the stromal vascular compartment)
Time Frame: Baseline and at 12 weeks
Changes in various adipose tissue immune cells including M1-like and M2-like macrophages, T helper cells, and cytotoxic T cells will be measured via flow cytometry.
Baseline and at 12 weeks
Concentrations of Circulatory cytokines and adipokines
Time Frame: Baseline and at 12 weeks
Changes in cytokines and adipokines will be measured via ELISA. We will measure markers including interleukin 6, tumour necrosis factor a, leptin, and adiponectin.
Baseline and at 12 weeks
Resting energy expenditure
Time Frame: Baseline and at 12 weeks
Resting energy expenditure will be measured in a fasted state by indirect calorimetry. Volume of oxygen and carbon dioxide and water vapor pressure will be taken into consideration to calculate the resting energy expenditure.
Baseline and at 12 weeks
Substrate oxidation
Time Frame: Baseline and at 12 weeks
Substrate oxidation will be measured in a fasted state by indirect calorimetry. Volume of oxygen and carbon dioxide and water vapor pressure will be taken into consideration to calculate the respiratory exchange ratio.
Baseline and at 12 weeks
Lipidomics
Time Frame: Baseline and at 12 weeks
Lipidomics will be measured by mass spectrometry.
Baseline and at 12 weeks
Adipocyte size
Time Frame: Baseline and at 12 weeks
Regional adipocyte characteristics will be measured in vitro including adipocyte size,
Baseline and at 12 weeks
Rate of pre-adipocyte proliferation
Time Frame: Baseline and at 12 weeks
Regional adipose tissue pre-adipocyte proliferation rate will be measured in vitro
Baseline and at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Concordia University, Montreal

Investigators

  • Principal Investigator: Sylvia Santsa, PhD, Concordia University, Montreal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

July 31, 2024

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90000185

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

On request and approval by ethics

IPD Sharing Time Frame

The data will be available after the study results have been accepted for publication. The data will be available for 5 y.

IPD Sharing Access Criteria

On request with ethics approval.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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